Clinical Trial 20337

• Overview

  Study Title:

  Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living with HIV

  Summary:

  This is a randomized, double-blinded, placebo-controlled Phase III interventional trial of the nine-valent HPV vaccine (9vHPV) to prevent persistent oral HPV infection in adult cisgender men and transgender women living with HIV.

  Objective:

  1.1 Primary Objectives 1.1.1 To demonstrate that 9vHPV when given in a 3-dose regimen (Day 1, Months 2 and 6) reduces the incidence of persistent oral HPV infection with 9-valent HPV vaccine types 6, 11, 16, 18, 31, 33, 45, 52, and 58, a surrogate for HPV associated oropharyngeal cancer, in men living with HIV ages 20-50 years who are oral HPV negative to the relevant HPV type at enrollment, compared with placebo. 1.2 Secondary Objectives 1.2.1 To evaluate the vaccine-induced serum anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 responses in a subset of men living with HIV age 20-50 year old men. 1.2.2 To evaluate the safety and tolerability of 9vHPV in men living with HIV. 1.3 Exploratory Objectives 1.3.1 To establish a biorepository for future analyses to characterize vaccine-induced serum and oral immune responses and oral HPV natural history. 1.3.2 To archive genital and anal samples for future investigation related to vaccine efficacy for the prevention of genital and anal 9vHPV vaccine types, and oral and genital HPV natural history.

• Inclusion Criteria

  Inclusion Criteria:
  • HIV-1 infection
  • Receipt of antiretroviral therapy for at least 6 months
  • Sexually active in the past 6 months; sexual activity is defined as insertive penile-vaginal sex, receptive or insertive penile-anal sex, oral-anal sex, or oral-genital sex Willingness to comply with three-dose vaccine schedule and subsequent six-month visits for up to four years after randomization.
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Have a history of oropharyngeal cancer (OPC) or other HPV-related cancer or have suspected OPC or other HPV-related cancer;
  • Have received any doses of a licensed or experimental HPV vaccine or have participated in an HPV vaccine study,
  • Have a history of anaphylaxis to vaccines or are allergic to any vaccine component (e.g.aluminum, yeast, benzonase);
  • Have received any blood products within six months of enrollment, or are currently taking immune-suppressants.
  • Currently have warts/lesions in the oral cavity.
  • Plan to relocate during the study period.
  • Have AIDS-defining condition within 6 months prior to study entry.
  • Other criteria may apply

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